Manager, Validation

Boehringer PRD; Saint Joseph (LA); On-site; USD 120,000 - 190,000; Full time

Job summary

Boehringer Ingelheim in the United States seeks a senior validation leader to oversee equipment, process, systems and product validation for Pharmaceuticals and Vaccines at the Saint Joseph site. The role ensures compliance with cGMP, FDA, EU, USDA and BI standards, directing budgets and projects and maintaining the Validation Master Plan (VMP) to support current regulations.

Collaborating with Product and Engineering, the incumbent leads cross-functional teams, analyzes data and ensures

Qualifications

• Bachelor's degree in a scientific, bioengineering, or related discipline; minimum 10 years GMP validation experience in a GMP or regulated environment.
• In lieu of a degree, at least 15 years GMP validation experience in a GMP or regulated environment.

Responsibilities

• Manages personnel, budgets and projects related to systems, process, cleaning and equipment validation in GXP areas (Operations, R&D, Marketing) at the facility.
• Maintains comprehensive electronic data base for tracking compliance and qualification status of critical GXP equipment, systems and processes.
• Identifies regulatory compliance trends for validation procedures and updates the VMP to ensure ongoing compliance.
• Supports Product and Engineering in selecting, reviewing, acquiring, and upgrading production equipment to enable IQ/OQ/PQ validation.

Skills

GMP validation leadership

Regulatory compliance

Cross-functional leadership

Data analysis & statistics

Project management

Education

Bachelor degree in scientific discipline

Tools

GxP documentation systems

Job description

Description

This position manages all equipment, process, systems and product related validation activities, except GXP related computerized systems for both Pharmaceuticals and Vaccines at the site . The position is critical to the compliance effort for both pharmaceuticals and vaccines and is responsible for assuring compliance of validated systems, process, equipment to current cGMP, FDA, EU, USDA and BI corporate requirements. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.

Duties & Responsibilities

• Manages personnel, budgets and projects relating to systems, process, cleaning and equipment validation in GXP relevant areas such as Operations, R’D, Marketing at the facility.
• Maintains comprehensive electronic data base for tracking compliance and qualification status of all critical GXP relevant equipment, systems and processes.
• Identifies current trends in regulatory compliance for all validation procedures for equipment, systems and processes. Implements and updates the validation master plan (VMP) to assure compliance with regulatory and corporate requirements.
• Supports Product and Engineering Departments in the selection, review, acquisition, and upgrade of production equipment to assure future IQ/OQ/PQscan be performed on equipment sourced.

Requirements

• Bachelor degreefrom an accredited institutionin a scientific, bioengineering, or relevant discipline required, and a minimum of ten (10) years GMP validation experience in a GMP OR regulated manufacturing or similar environment.
• In lieu of a degree, a minimum of fifteen (15) years GMP validation experience in a GMP OR regulated manufacturing or similar environment.
• Experience must be inclusive of at least three (3) years in a leadership role leading people and/or projects.
• Shares technical and compliance knowledge horizontally and vertically across the site.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross-functional teams.
• Strong knowledge of statistics, data bases, and quality principles.
• Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
• Must be self motivated and of high integrity.

Desired Skills, Experience and Abilities